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Production Technician

2 months ago

Durham, United States Advanced Recruiting Partners Full time


Production Technician 

Job Purpose

The Production Technician II is responsible for the safe manufacture of active pharmaceutical ingredients (APIs) and drug products in a Good Manufacturing Process (GMP) environment. This position will operate, clean, and maintain manufacturing equipment, instrumentation, and facilities necessary to support GMP production processes in API manufacturing.

Essential Duties & Responsibilities

Operations Execution
Execute API/Drug Product manufacturing operations in the Company's current Good Manufacturing Process facility:

Request and dispense raw materials for manufacture

Operate process reactors, filters, dryers, fillers, milling, and formulation equipment

Sample product as directed for testing

Clean and maintain production equipment and areas

Maintain a safe working environment

Observe and follow all safe operation practices

Waste management

Documentation
Complete and maintain documentation in accordance with expected Good Documentation Practices (GDP):

Follow and complete batch records

Fill out and review logbooks

Follow standard operating procedures (SOPs)

Ability to revise GMP documents required

Assist in deviation investigations and all other forms of GMP documentation

Maintenance and Instrumentation Support
Maintain equipment and instrumentation necessary to support cGMP manufacture of APIs as described in production batch records:

Participate in preventative maintenance activities

Assist in maintaining equipment records

Suggest and implement improvements to operations

Monitor environmental parameters

Maintain inventory of consumables and supplies

Other

Perform other duties as assigned

Ability to wear a powered air purifying respirator required

 

Education, Skills, and Experience

Education
· HS degree, GED, or equivalent experience

· Bachelor’s degree preferred

Knowledge and Skills
· Strong mechanical aptitude and critical thinking

· Proficient with computers and basic math

· Attention to detail and documentation

· Ability to follow written and verbal technical instruction

· Strong verbal and written communication skills

· Proficiency in MS office required

Experience
· Experience with cleaning, maintaining, and controlling equipment

· 2-4 years’ experience in a GMP manufacturing environment or equivalent

· Experience with cleaning, maintain, and controlling qualified equipment

· SOP writing experience preferred

· Ability to write deviations and validation protocols preferred

· Experience training others preferred